- Fiasp® is a man-made insulin used to control high blood sugar in adults and children with diabetes mellitus.
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For use with Fiasp® or NovoLog® PenFill® cartridges
What is Fiasp®?
Important Safety Information
Do not share your Fiasp® with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them.
Who should not take Fiasp®?
Do not take Fiasp® if:
- your blood sugar is too low (hypoglycemia) or you have an allergy to insulin aspart or any of the ingredients in Fiasp®.
Before taking Fiasp® tell your health care provider about all your medical conditions including, if you:
- have kidney or liver problems
- are pregnant or breastfeeding or plan to become pregnant or breastfeed. It is not known if Fiasp® passes into your breast milk.
- are taking new prescription or over-the-counter medicines, including supplements.
Talk to your health care provider about low blood sugar and how to manage it.
How should I take Fiasp®?
- Read the Instructions for Use and take Fiasp® exactly as your health care provider tells you to.
- Fiasp® starts acting fast. You should take your dose of Fiasp® at the beginning of the meal or within 20 minutes after starting a meal.
- Know the type and strength of your insulin. Do not change your insulin type unless your health care provider tells you to.
Change (rotate) your injection sites within the area you choose with each injection to reduce your risk of getting pits in skin or thickened skin (lipodystrophy) and skin with lumps (localized cutaneous amyloidosis) at the injection sites.
- Do not use the exact same spot for each injection.
- Do not inject where the skin has pits, is thickened, or has lumps.
- Do not inject where the skin is tender, bruised, scaly or hard, or into scars or damaged skin.
- If you miss a dose of Fiasp® monitor your blood sugar levels to decide if an insulin dose is needed. Continue with your regular dosing schedule at the next meal.
- Check your blood sugar levels. Ask your health care provider what your blood sugar levels should be and when you should check them.
- Do not reuse or share your needles with other people. You may give other people a serious infection or get a serious infection from them.
What should I avoid while taking Fiasp®?
- Do not drive or operate heavy machinery, until you know how Fiasp® affects you.
- Do not drink alcohol or use medicines that contain alcohol.
What are the possible side effects of Fiasp®?
Serious side effects can lead to death, including:
- Low blood sugar (hypoglycemia). Some signs and symptoms include: anxiety, irritability, mood changes, dizziness or light-headedness, sweating, blurred vision, slurred speech, hunger, confusion, headache, shakiness, and fast heart beat.
- low potassium in your blood (hypokalemia).
- serious allergic reactions (whole body reactions). Get emergency medical help right away if you have a rash over your whole body; trouble breathing; a fast heartbeat; swelling of your face, tongue or throat; sweating; extreme drowsiness; dizziness, or confusion.
- heart failure. Taking certain diabetes pills called TZDs (thiazolidinediones) with Fiasp® may cause heart failure in some people. This can happen even if you have never had heart failure or heart problems before. If you already have heart failure it may get worse while you take TZDs with Fiasp®. Your health care provider should monitor you closely while you are taking TZDs with Fiasp®. Tell your health care provider if you have any new or worse symptoms of heart failure including shortness of breath, swelling of your ankles or feet, or sudden weight gain.
Your insulin dose may need to change because of:
- weight gain or loss, increased stress, illness, or change in diet or level of physical activity
Common side effects of Fiasp® may include:
- skin problems such as eczema, rash, itching, redness and swelling of your skin (dermatitis), reactions at the injection site such as itching, rash, skin thickening or pits at the injection site (lipodystrophy), or weight gain.
Please see Precribing Information for Fiasp®.
Fiasp® is a prescription medication.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1‑800‑FDA‑1088.
What is Levemir®?
- Levemir® is a man-made insulin used to control high blood sugar in adults and children with diabetes mellitus.
- Levemir® is not for people with diabetic ketoacidosis (increased ketones in the blood or urine).
Important Safety Information
Do not share your Levemir® FlexPen® with other people, even if the needle has been changed. Do not share needles or syringes with another person. You may give other people a serious infection or get a serious infection from them.
Who should not take Levemir®?
Do not take Levemir® if:
- you are having an episode of low blood sugar (hypoglycemia).
- you have an allergy to Levemir® or any of the ingredients in Levemir®.
Before taking Levemir®, tell your healthcare provider about all your medical conditions including, if you:
- take any other medicines, especially medicines commonly called TZDs (thiazolidinediones)
- are pregnant, plan to become pregnant, or are breastfeeding.
Tell your healthcare provider all the medicines you take, including prescription and over-the-counter medicines, vitamins, or herbal supplements. Before you start taking Levemir®, talk to your healthcare provider about low blood sugar and how to manage it.
How should I take Levemir®?
- Read the Instructions for Use and take exactly as directed.
- Know the type and strength of your insulin. Do not change your insulin type unless your healthcare provider tells you to.
- Check your blood sugar levels. Ask your healthcare provider what your blood sugar levels should be and when you should check your blood sugar levels.
- Do not reuse or share your needles or syringes with other people. You may give other people a serious infection or get a serious infection from them.
- Do not inject Levemir® into a vein or muscle.
- Change (rotate) your injection sites within the area you choose with each injection to reduce your risk of getting lipodystrophy (pits in skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the injection sites.
- Do not use the exact same spot for each injection.
- Do not inject where the skin has pits, is thickened, or has lumps.
- Do not inject where the skin is tender, bruised, scaly or hard, or into scars or damaged skin.
What should I avoid while taking Levemir®?
- Do not drive or operate heavy machinery, until you know how it affects you.
- Do not drink alcohol or use medicines that contain alcohol.
What are the possible side effects of Levemir®?
Serious side effects can lead to death, including:
- low blood sugar (hypoglycemia). Low blood sugar can be a serious, but common side effect of Levemir®. Signs and symptoms that may indicate low blood sugar include dizziness, light-headedness, sweating, confusion, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability, mood changes, and hunger.
- severe allergic reactions. Severe allergic reactions are a potential side effect of Levemir®. Get emergency medical help if you have trouble breathing, shortness of breath, fast heartbeat, swelling, swelling of your face, tongue, or throat, sweating, extreme drowsiness, dizziness, or confusion.
- low potassium in your blood (hypokalemia)
- heart failure. Taking certain diabetes pills called TZDs (thiazolidinediones) with Levemir® may cause heart failure in some people. This can happen even if you have never had heart failure or heart problems before. If you already have heart failure, it may get worse while you take TZDs with Levemir®. Tell your healthcare provider if you have new or worse symptoms of heart failure including shortness of breath, swelling of ankles or feet, and sudden weight gain. Treatment with TZDs and Levemir® may need to be changed or stopped by your healthcare provider if you have new or worse heart failure.
Other common side effects include:
- injection site reactions, skin thickening or pits at the injection site (lipodystrophy), weight gain, swelling of your hands and feet, rash, and itching.
Your insulin dose may need to change because of:
- change in level of physical activity or exercise, weight gain or loss, increased stress, illness, or change in diet.
Please see Prescribing Information for Levemir®.
Levemir® is a prescription medication.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1‑800‑FDA‑1088.
What is NovoLog®?
- NovoLog® is a man-made insulin used to control high blood sugar in adults and children with diabetes mellitus.
Important Safety Information
Do not share your NovoLog® FlexPen®, NovoLog® FlexTouch®, PenFill® cartridge or PenFill® cartridge compatible insulin delivery device with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them.
Who should not take NovoLog®?
Do not take NovoLog® if:
- your blood sugar is too low (hypoglycemia) or you are allergic to NovoLog® or any of its ingredients.
Before taking NovoLog®, tell your health care provider about all your medical conditions including, if you are:
- pregnant, plan to become pregnant, or are breastfeeding.
- taking new prescription or over-the-counter medicines, including supplements.
Talk to your health care provider about how to manage low blood sugar.
How should I take NovoLog®?
- Read the Instructions for Use and take exactly as directed.
- NovoLog® starts acting fast. Eat a meal within 5 to 10 minutes after taking it.
- Know the type and strength of your insulin. Do not change your insulin type unless your health care provider tells you to.
- Check your blood sugar levels. Ask your health care provider what your blood sugar levels should be and when you should check them.
- Do not reuse or share your needles with other people. You may give other people a serious infection, or get a serious infection from them.
- Change (rotate) your injection sites within the area you choose with each injection to reduce your risk of getting lipodystrophy (pits in skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the injection sites.
- Do not use the exact same spot for each injection.
- Do not inject where the skin has pits, is thickened, or has lumps.
- Do not inject where the skin is tender, bruised, scaly or hard, or into scars or damaged skin.
What should I avoid while taking NovoLog®?
- Do not drive or operate heavy machinery, until you know how NovoLog® affects you.
- Do not drink alcohol or use medicines that contain alcohol.
What are the possible side effects of NovoLog®?
Serious side effects can lead to death, including:
Low blood sugar. Some signs and symptoms include:
- anxiety, irritability, mood changes, dizziness, sweating, confusion, and headache.
Your insulin dose may need to change because of:
- weight gain or loss, increased stress, illness, or change in diet or level of physical activity.
Other common side effects may include:
- low potassium in your blood, injection site reactions, itching, rash, serious whole body allergic reactions, skin thickening or pits at the injection site, weight gain, and swelling of your hands and feet.
Get emergency medical help if you have:
- trouble breathing, shortness of breath, fast heartbeat, swelling of your face, tongue, or throat, sweating, extreme drowsiness, dizziness, or confusion.
Please see Prescribing Information for NovoLog®.
NovoLog® is a prescription medication.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1‑800‑FDA‑1088.
What is NovoLog® Mix 70/30?
- NovoLog® Mix 70/30 is a man-made insulin used to control high blood sugar in people with diabetes mellitus.
- It is not known if NovoLog® Mix 70/30 is safe and effective in children.
Important Safety Information
Do not share your NovoLog® Mix 70/30 FlexPen® with other people, even if the needle has been changed. Do not share needles or syringes with another person. You may give other people a serious infection, or get a serious infection from them.
Who should not take NovoLog® Mix 70/30?
- Do not take NovoLog® Mix 70/30 if you are having an episode of low blood sugar (hypoglycemia) or you have an allergy to NovoLog® Mix 70/30 or any of its ingredients.
Before taking NovoLog® Mix 70/30, tell your healthcare provider about all your medical conditions including, if you are:
- pregnant, planning to become pregnant, or are breastfeeding.
- taking new prescription or over-the-counter medicines, including supplements.
Before you start taking NovoLog® Mix 70/30, talk to your health care provider about low blood sugar and how to manage it.
How should I take NovoLog® Mix 70/30?
- Read the Instructions for Use and take exactly as directed by your healthcare provider.
- NovoLog® Mix 70/30 starts acting fast. If you have type 1 diabetes, inject within 15 minutes before you eat a meal. Do not inject NovoLog® Mix 70/30 if you are not planning to eat within 15 minutes. If you have type 2 diabetes, you may inject up to 15 minutes before or after starting your meal.
- Do not mix NovoLog® Mix 70/30 with other insulin products or use in an insulin pump.
- Know the type and strength of your insulin. Do not change your insulin type unless your health care provider tells you to.
- Check your blood sugar levels. Ask your health care provider what your blood sugar levels should be and when you should check them.
- Do not reuse or share your needles or syringes with other people. You may give other people a serious infection, or get a serious infection from them.
- NovoLog® Mix 70/30 is injected under the skin (subcutaneously) of your stomach area, buttocks, upper legs, or upper arms.
- Change (rotate) your injection sites within the area you choose with each injection to reduce your risk of getting lipodystrophy (pits in skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the injection sites.
- Do not use the exact same spot for each injection.
- Do not inject where the skin has pits, is thickened, or has lumps.
- Do not inject where the skin is tender, bruised, scaly or hard, or into scars or damaged skin.
What should I avoid while taking NovoLog® Mix 70/30?
- Do not drive or operate heavy machinery, until you know how NovoLog® Mix 70/30 affects you.
- Do not drink alcohol or use medicines that contain alcohol.
What are the possible side effects of NovoLog® Mix 70/30?
Serious side effects can lead to death, including:
Low blood sugar (hypoglycema). Some signs and symptoms include:
- Dizziness, light-headedness, sweating, confusion, headache, blurred vision, slurred speech, shakiness, fast heart rate, anxiety, irritability, mood changes, and hunger.
Your insulin dose may need to change because of:
- weight gain or loss, increased stress, illness, or change in diet or level of physical activity.
Other common side effects may include:
- low potassium in your blood (hypokalemia), reactions at the injection site, itching, rash, serious allergic reactions (whole body reactions), skin thickening or pits at the injection site (lipodystrophy), weight gain, and swelling of your hands and feet.
Get emergency medical help if you have:
- trouble breathing, shortness of breath, fast heartbeat, swelling of your face, tongue, or throat, sweating, extreme drowsiness, dizziness, or confusion.
Please see Prescribing Information for NovoLog® Mix 70/30.
NovoLog® Mix 70/30 is a prescription medication.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1‑800‑FDA‑1088.
Important Safety Information for Ozempic®
Do not share your Ozempic® pen with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them.
What is the most important information I should know about Ozempic®?
Ozempic® may cause serious side effects, including:
- Possible thyroid tumors, including cancer. Tell your health care provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In studies with rodents, Ozempic® and medicines that work like Ozempic® caused thyroid tumors, including thyroid cancer. It is not known if Ozempic® will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people.
- Do not use Ozempic® if you or any of your family have ever had MTC, or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
What is Ozempic®?
Ozempic® (semaglutide) injection 0.5 mg, 1 mg, or 2 mg is an injectable prescription medicine used:
- along with diet and exercise to improve blood sugar (glucose) in adults with type 2 diabetes mellitus.
- to reduce the risk of major cardiovascular events such as heart attack, stroke, or death in adults with type 2 diabetes mellitus with known heart disease.
It is not known if Ozempic® can be used in people who have had pancreatitis.
Ozempic® is not for use in people with type 1 diabetes.
It is not known if Ozempic® is safe and effective for use in children under 18 years of age.
Important Safety Information
What is the most important information I should know about Ozempic®?
Do not use Ozempic® if:
- you or any of your family have ever had MTC or if you have MEN 2.
- you are allergic to semaglutide or any of the ingredients in Ozempic®. See symptoms of serious allergic reaction in “What are the possible side effects of Ozempic®?”.
Before using Ozempic®, tell your health care provider if you have any other medical conditions, including if you:
- have or have had problems with your pancreas or kidneys.
- have a history of diabetic retinopathy.
- are pregnant or breastfeeding or plan to become pregnant or breastfeed. It is not known if Ozempic® will harm your unborn baby or passes into your breast milk. You should stop using Ozempic® 2 months before you plan to become pregnant.
Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, herbal supplements, and other medicines to treat diabetes, including insulin or sulfonylureas.
What are the possible side effects of Ozempic®?
Ozempic® may cause serious side effects, including:
- inflammation of your pancreas (pancreatitis). Stop using Ozempic® and call your health care provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back.
- changes in vision. Tell your health care provider if you have changes in vision during treatment with Ozempic®.
- low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Ozempic® with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin. Signs and symptoms of low blood sugar may include: dizziness or lightheadedness, blurred vision, anxiety, irritability or mood changes, sweating, slurred speech, hunger, confusion or drowsiness, shakiness, weakness, headache, fast heartbeat, and feeling jittery.
- kidney problems (kidney failure). In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems to get worse. It is important for you to drink fluids to help reduce your chance of dehydration.
- serious allergic reactions. Stop using Ozempic® and get medical help right away if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue, or throat; problems breathing or swallowing; severe rash or itching; fainting or feeling dizzy; or very rapid heartbeat.
- gallbladder problems. Gallbladder problems have happened in some people who take Ozempic®. Tell your healthcare provider right away if you get symptoms which may include: pain in your upper stomach (abdomen), fever, yellowing of the skin or eyes (jaundice), or clay-colored stools.
The most common side effects of Ozempic® may include nausea, vomiting, diarrhea, stomach (abdominal) pain, and constipation.
Please see Prescribing Information and Medication Guide for Ozempic®.
Ozempic® is a prescription medication.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1‑800‑FDA‑1088.
Important Safety Information for RYBELSUS®
What is the most important information I should know about RYBELSUS®?
RYBELSUS® may cause serious side effects, including:
- Possible thyroid tumors, including cancer. Tell your healthcare provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In studies with rodents, RYBELSUS® and medicines that work like RYBELSUS® caused thyroid tumors, including thyroid cancer. It is not known if RYBELSUS® will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people
Do not use RYBELSUS® if:
- you or any of your family have ever had MTC, or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
- you have had a serious allergic reaction to semaglutide or any of the ingredients in RYBELSUS®. See symptoms of serious allergic reaction in “What are the possible side effects of RYBELSUS®?”
What is RYBELSUS®?
RYBELSUS® (semaglutide) tablets 7 mg or 14 mg is a prescription medicine used along with diet and exercise to improve blood sugar (glucose) in adults with type 2 diabetes.
- It is not known if RYBELSUS® can be used in people who have had pancreatitis
- RYBELSUS® is not for use in people with type 1 diabetes
- It is not known if RYBELSUS® is safe and effective for use in children under 18 years of age
Important Safety Information
Before using RYBELSUS®, tell your healthcare provider if you have any other medical conditions, including if you:
- have or have had problems with your pancreas or kidneys
- have a history of vision problems related to your diabetes
- are pregnant or plan to become pregnant. It is not known if RYBELSUS® will harm your unborn baby. You should stop using RYBELSUS® 2 months before you plan to become pregnant. Talk to your healthcare provider about the best way to control your blood sugar if you plan to become pregnant or while you are pregnant
- are breastfeeding or plan to breastfeed. Breastfeeding is not recommended during treatment with RYBELSUS®
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. RYBELSUS® may affect the way some medicines work and some medicines may affect the way RYBELSUS® works.
How should I take RYBELSUS®?
- Take RYBELSUS® exactly as your healthcare provider tells you to
- Take RYBELSUS® by mouth on an empty stomach when you first wake up with a sip of plain water (no more than 4 ounces)
- Do not split, crush, or chew. Swallow RYBELSUS® whole
- After 30 minutes, you can eat, drink, or take other oral medicines
- If you miss a dose of RYBELSUS®, skip the missed dose and go back to your regular schedule
What are the possible side effects of RYBELSUS®?
RYBELSUS® may cause serious side effects, including:
- inflammation of your pancreas (pancreatitis). Stop using RYBELSUS® and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back
- changes in vision. Tell your healthcare provider if you have changes in vision during treatment with RYBELSUS®
- low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use RYBELSUS® with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin. Signs and symptoms of low blood sugar may include: dizziness or lightheadedness, blurred vision, anxiety, irritability or mood changes, sweating, slurred speech, hunger, confusion or drowsiness, shakiness, weakness, headache, fast heartbeat, and feeling jittery
- kidney problems (kidney failure). In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems to get worse. It is important for you to drink fluids to help reduce your chance of dehydration
- serious allergic reactions. Stop using RYBELSUS® and get medical help right away, if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue, or throat; problems breathing or swallowing; severe rash or itching; fainting or feeling dizzy; or very rapid heartbeat
- gallbladder problems. Gallbladder problems have happened in some people who take RYBELSUS®. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include: pain in your upper stomach (abdomen), yellowing of skin or eyes (jaundice), fever, and clay-colored stools
The most common side effects of RYBELSUS® may include nausea, stomach (abdominal) pain, diarrhea, decreased appetite, vomiting, and constipation. Nausea, vomiting, and diarrhea are most common when you first start RYBELSUS®.
Please see Prescribing Information and Medication Guide for RYBELSUS®.
RYBELSUS® is a prescription medication.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1‑800‑FDA‑1088.
What is Tresiba®?
- Prescription Tresiba® is a long-acting insulin used to control high blood sugar in adults and children who are 1 year of age and older with diabetes
- Tresiba® is not for people with diabetic ketoacidosis (increased ketones in the blood or urine)
- It is not known if Tresiba® is safe and effective in children under 1 year of age
- Tresiba® is available in 2 concentrations: 200 units/mL and 100 units/mL
Important Safety Information
Do not share your Tresiba® FlexTouch® with other people, even if the needle has been changed. Do not share needles or syringes with another person. You may give other people a serious infection, or get a serious infection from them.
Who should not take Tresiba®?
Do not take Tresiba® if you:
- are having an episode of low blood sugar (hypoglycemia)
- have an allergy to Tresiba® or any of the ingredients in Tresiba®
Before taking Tresiba®, tell your health care provider about all your medical conditions, including if you are:
- pregnant, planning to become pregnant, or are breastfeeding
- taking new prescription or over-the-counter medicines, vitamins, or herbal supplements
Talk to your health care provider about low blood sugar and how to manage it.
How should I take Tresiba®?
- Read the Instructions for Use and take Tresiba® exactly as your health care provider tells you to
- Do not do any conversion of your dose. The dose counter always shows the selected dose in units
- Know the type and strength of insulin you take. Do not change the type of insulin you take unless your health care provider tells you to
- Adults - If you miss or are delayed in taking your dose of Tresiba®:
- Take your dose as soon as you remember, then continue with your regular dosing schedule
- Make sure there are at least 8 hours between doses
- Take your dose as soon as you remember, then continue with your regular dosing schedule
- If children miss a dose of Tresiba®:
- Call the healthcare provider for information and instructions about checking blood sugar levels more often until the next scheduled dose of Tresiba®
- For children who need less than 5 units of Tresiba® each day, use a Tresiba® U-100 vial
- Check your blood sugar levels. Ask your health care provider what your blood sugar levels should be and when you should check them
- Do not reuse or share your needles or syringes with other people. You may give them a serious infection, or get a serious infection from them
- Never inject Tresiba® into a vein or muscle
- Never use a syringe to remove Tresiba® from the FlexTouch® pen
- Tresiba® can be injected under the skin (subcutaneously) of your upper legs (thighs), upper arms, or stomach area (abdomen).
- Change (rotate) your injection sites within the area you choose with each injection to reduce your risk of getting lipodystrophy (pits in skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the injection sites.
- Do not use the exact same spot for each injection.
- Do not inject where the skin has pits, is thickened, or has lumps.
- Do not inject where the skin is tender, bruised, scaly or hard, or into scars or damaged skin.
What should I avoid while taking Tresiba®?
- Do not drive or operate heavy machinery, until you know how Tresiba® affects you
- Do not drink alcohol or use prescription or over-the-counter medicines that contain alcohol
What are the possible side effects of Tresiba®?
Tresiba® may cause serious side effects that can be life-threatening, including:
- Low blood sugar (hypoglycemia). Signs and symptoms that may indicate low blood sugar include dizziness, light-headedness, sweating, confusion, headache, blurred vision, slurred speech, shakiness, fast heart beat, anxiety, irritability, mood changes, and hunger.
- Low potassium in your blood (hypokalemia)
- Heart failure in some people if taken with thiazolidinediones (TZDs). This can happen even if you have never had heart failure or heart problems. If you already have heart failure, it may get worse while you take TZDs with Tresiba®. Tell your health care provider if you have any new or worse symptoms of heart failure including shortness of breath, tiredness, swelling of your ankles or feet, and sudden weight gain
Your insulin dose may need to change because of change in level of physical activity or exercise, increased stress, change in diet, weight gain or loss, or illness.
- Common side effects may include serious allergic reactions (whole body reactions), reactions at the injection site, skin thickening or pits at the injection site (lipodystrophy), itching, rash, swelling of your hands and feet, and weight gain.
Get emergency medical help if you have trouble breathing, shortness of breath, fast heartbeat, swelling of your face, tongue, or throat, sweating, extreme drowsiness, dizziness, or confusion.
Please see Prescribing Information for Tresiba®.
Tresiba® is a prescription medication.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1‑800‑FDA‑1088.
Important Safety Information for Victoza®
What is the most important information I should know about Victoza®?
Victoza® may cause serious side effects, including:
- Possible thyroid tumors, including cancer. Tell your health care provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In studies with rats and mice, Victoza® and medicines that work like Victoza® caused thyroid tumors, including thyroid cancer. It is not known if Victoza® will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people.
Who should not use Victoza®?
Do not use Victoza® if:
- you or any of your family have ever had MTC or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
- you are allergic to liraglutide or any of the ingredients in Victoza®. See symptoms of serious allergic reaction in "What are the possible side effects of Victoza®?".
What is Victoza®?
Victoza® (liraglutide) injection 1.2 mg or 1.8 mg is an injectable prescription medicine used:
- along with diet and exercise to lower blood sugar (glucose) in adults and children who are 10 years of age and older with type 2 diabetes mellitus
- to reduce the risk of major cardiovascular events such as heart attack, stroke or death in adults with type 2 diabetes mellitus with known heart disease.
Victoza® is not for use in people with type 1 diabetes. It should not be used with other medicines that contain liraglutide. It is not known if Victoza® is safe and effective to lower blood sugar in children under 10 years of age.
Important Safety Information
What should I tell my health care provider before using Victoza®?
Before using Victoza®, tell your health care provider if you:
- have or have had problems with your pancreas, kidneys, or liver.
- have any other medical conditions or severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems with digesting food.
- are pregnant or breastfeeding or plan to become pregnant or breastfeed.
Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, herbal supplements, and other medicines to treat diabetes, including insulin or sulfonylureas.
How should I use Victoza®?
- Inject under the skin of your stomach (abdomen), thigh, or upper arm. Do not inject Victoza® into a muscle or vein.
- Change (rotate) your injection site within the area you choose with each injection to reduce your risk of getting lumps under the skin (cutaneous amyloidosis). Do not use the same site for each injection.
- Do not mix insulin and Victoza® together in the same injection.
- You may give an injection of Victoza® and insulin in the same body area (such as your stomach area), but not right next to each other.
- Do not share your Victoza® pen with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them.
What are the possible side effects of Victoza®?
Victoza® may cause serious side effects, including:
- inflammation of your pancreas (pancreatitis). Stop using Victoza® and call your health care provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back.
- low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Victoza® with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin. In children who are 10 years of age and older, the risk for low blood sugar may be higher with Victoza® regardless of use with another medicine that can also lower blood sugar. Signs and symptoms of low blood sugar may include: dizziness or lightheadedness, blurred vision, anxiety, irritability or mood changes, sweating, slurred speech, hunger, confusion or drowsiness, shakiness, weakness, headache, fast heartbeat, and feeling jittery.
- kidney problems (kidney failure). In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems to get worse.
- serious allergic reactions. Stop using Victoza® and get medical help right away if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy, or a very rapid heartbeat.
- gallbladder problems. Gallbladder problems have happened in some people who take Victoza®. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include pain in the upper stomach (abdomen), fever, yellowing of skin or eyes (jaundice), or clay-colored stools.
The most common side effects of Victoza® may include nausea, diarrhea, vomiting, decreased appetite, indigestion, and constipation.
Please see Prescribing Information and Medication Guide for Victoza®.
Victoza® is a prescription medication.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1‑800‑FDA‑1088.
Important Safety Information for Xultophy® 100/3.6
What is the most important information I should know about Xultophy® 100/3.6?
Xultophy® 100/3.6 may cause serious side effects, including:
- Possible thyroid tumors, including cancer. Tell your health care provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In studies with rats and mice, liraglutide, one of the components of Xultophy® 100/3.6, and medicines that work like liraglutide caused thyroid tumors, including thyroid cancer. It is not known if Xultophy® 100/3.6 will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people.
What is Xultophy® 100/3.6?
Xultophy® 100/3.6 is an injectable prescription medicine that contains 2 diabetes medicines, insulin degludec, 100 units/mL, and liraglutide, 3.6 mg/mL. Xultophy® 100/3.6 should be used along with diet and exercise to lower blood sugar (glucose) in adults with type 2 diabetes mellitus.
- Xultophy® 100/3.6 is not recommended as the first choice of medicine for treating diabetes.
- Xultophy® 100/3.6 is not recommended for use in combination with any other product containing liraglutide or another glucagon like peptide 1 receptor agonist (GLP-1 RA).
- Xultophy® 100/3.6 is not for use in people with type 1 diabetes or people with diabetic ketoacidosis (increased ketones in the blood or urine).
- It is not known if Xultophy® 100/3.6 can be used with mealtime insulin.
- It is not known if Xultophy® 100/3.6 is safe and effective for use in children.
Important Safety Information
Who should not use Xultophy® 100/3.6?
Do not use Xultophy® 100/3.6 if:
- you or any of your family have ever had MTC or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
- you are having an episode of low blood sugar or if you are allergic to insulin degludec, liraglutide, or any of the ingredients in Xultophy® 100/3.6.
What should I tell my health care provider before using Xultophy® 100/3.6?
Tell your health care provider about all your medical conditions, including if you:
- have or have had problems with your pancreas, kidneys, or liver.
- have heart failure or other heart problems. If you have heart failure, it may get worse while you take TZDs (thiazolidinediones) with Xultophy® 100/3.6.
- have severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems with digesting food.
- are taking certain medicines called GLP-1 RA, or have had an allergic reaction to a GLP-1 RA.
- are pregnant or breastfeeding or plan to become pregnant or breastfeed. It is not known if Xultophy® 100/3.6 passes into your breast milk.
Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Before using Xultophy® 100/3.6, talk to your health care provider about low blood sugar and how to manage it.
How should I use Xultophy® 100/3.6?
- Read the Instructions for Use and take Xultophy® 100/3.6 exactly as your health care provider tells you.
- Do not change your dosing schedule without first talking to your health care provider.
- Do not inject Xultophy® 100/3.6 into a muscle or vein or use in an insulin infusion pump.
- Use Xultophy® 100/3.6 at the same time each day with or without food. Do not take more than 50 units of Xultophy® 100/3.6 each day.
- Check the Pen label each time you give your injection to make sure you are using the correct medicine.
- Change (rotate) your injection sites within the area you choose with each injection to reduce your risk of getting lipodystrophy (pits in skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the injection sites.
- Do not use the exact same spot for each injection.
- Do not inject where the skin has pits, is thickened, or has lumps.
- Do not inject where the skin is tender, bruised, scaly or hard, or into scars or damaged skin.
- Do not share your Xultophy® 100/3.6 pen with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them.
- Check your blood sugar levels. Ask your health care provider what your blood sugar levels should be and when you should check them.
Your dose of Xultophy® 100/3.6 may need to change because of change in level of physical activity or exercise, weight gain or loss, increased stress, illness, change in diet, or other medicines you take.
What should I avoid while taking Xultophy® 100/3.6?
- Do not drive or operate heavy machinery, until you know how Xultophy® 100/3.6 affects you. Do not drink alcohol or use prescription or over-the-counter medicines that contain alcohol.
What are the possible side effects of Xultophy® 100/3.6?
Xultophy® 100/3.6 may cause serious side effects that can be life-threatening, including:
- inflammation of your pancreas (pancreatitis). Stop using Xultophy® 100/3.6 and call your health care provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back.
- low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Xultophy® 100/3.6 with another medication that can cause low blood sugar. Signs and symptoms of low blood sugar may include: shakiness, irritability, fast heartbeat, dizziness, weakness, sweating, confusion, drowsiness, hunger, headache, and feeling jittery.
- kidney problems (kidney failure). Worsening of kidney failure and sudden kidney failure have happened in people with kidney problems and in people without kidney problems, who have taken liraglutide, one of the ingredients in Xultophy® 100/3.6. Diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration) which may cause kidney problems to get worse. Tell your health care provider if you have diarrhea, nausea, or vomiting. Drink plenty of fluids to help reduce your risk of dehydration during treatment with Xultophy® 100/3.6.
- serious allergic reactions. Stop using Xultophy® 100/3.6 and get medical help right away if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, problems breathing or swallowing, sudden coughing, chest pain or tightness, hives, rash, itching, fast heartbeat, or fainting or feeling dizzy.
- gallbladder problems. Gallbladder problems have happened in some people who take liraglutide, an ingredient in Xultophy® 100/3.6. Tell your health care provider right away if you get symptoms of gallbladder problems including pain in the right or middle upper stomach area, fever, yellowing of skin or eyes (jaundice), or clay-colored stools.
- low potassium in your blood (hypokalemia).
- heart failure. Taking certain diabetes medicines called TZDs with Xultophy® 100/3.6 may cause heart failure in some people. This can happen even if you have never had heart failure or heart problems. If you already have heart failure, it may get worse while you take TZDs with Xultophy® 100/3.6. Tell your health care provider if you have any new or worse symptoms of heart failure, including shortness of breath, tiredness, swelling of your ankles or feet, and sudden weight gain.
The most common side effects of Xultophy® 100/3.6 may include stuffy or runny nose, sore throat, headache, nausea, diarrhea, increased blood levels of lipase, and upper respiratory tract infection.
Please see Prescribing Information and Medication Guide for Xultophy® 100/3.6.
Xultophy® 100/3.6 is a prescription medication.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1‑800‑FDA‑1088.
What is ZEGALOGUE®?
ZEGALOGUE® (dasiglucagon) injection is a prescription medicine used to treat very low blood sugar (severe hypoglycemia) in people with diabetes aged 6 years and older. It is not known if ZEGALOGUE® is safe and effective in children under 6 years of age.
Important Safety Information
Do not use ZEGALOGUE® if you:
- have a tumor called pheochromocytoma in the gland on top of your kidneys (adrenal gland).
- have a tumor called insulinoma in your pancreas.
Before using ZEGALOGUE®, tell your healthcare provider about all of your medical conditions, including if you:
- have a tumor in your pancreas.
- are allergic to dasiglucagon, or any other ingredients in ZEGALOGUE®.
- have not had food or water for a long time (prolonged fasting or starvation).
- have adrenal insufficiency.
- have low blood sugar that does not go away (chronic hypoglycemia).
- are pregnant or plan to become pregnant.
- are breastfeeding or plan to breastfeed. It is not known if ZEGALOGUE® passes into your breast milk. You and your healthcare provider should decide if you can use ZEGALOGUE® while breastfeeding.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How should I use ZEGALOGUE®?
- Read the detailed Instructions For Use that come with ZEGALOGUE®.
- Use ZEGALOGUE® exactly how your healthcare provider tells you to use it.
- Make sure your caregiver knows where you keep your ZEGALOGUE® and how to use ZEGALOGUE® the right way before you need it.
- Your caregiver must act quickly. Having very low blood sugar for a period of time may be harmful.
- Your healthcare provider will tell you how and when to use ZEGALOGUE®.
- After giving ZEGALOGUE® your caregiver should call for emergency medical help right away.
- Once you are able to safely consume food or drink, your caregiver should give you a fast-acting source of sugar (such as fruit juice) and a long-acting source of sugar (such as crackers with cheese or peanut butter).
- If you do not respond to treatment after 15 minutes, your caregiver may give you another dose, if available.
- Tell your healthcare provider each time you use ZEGALOGUE®. Your healthcare provider may need to change the dose of your other diabetes medicines.
What are the possible side effects of ZEGALOGUE®?
- high blood pressure. ZEGALOGUE® can cause high blood pressure in certain people with tumors in their adrenal glands.
- low blood sugar. ZEGALOGUE® can cause certain people with tumors in their pancreas called insulinomas to have low blood sugar.
- serious allergic reaction. Call your healthcare provider or get medical help right away if you have a serious allergic reaction including: rash, difficulty breathing, low blood pressure (hypotension).
The most common side effects of ZEGALOGUE® include: in adults: nausea, vomiting, headache, diarrhea, and injection site pain; in children: nausea, vomiting, headache, and injection site pain. These are not all the possible side effects of ZEGALOGUE®.
Please see Prescribing Information for ZEGALOGUE®.
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